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The product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. The veterinary labelling is developed by the drug sponsor according to the Food and Drug Regulations. While Health Canada reviews the product monograph or the veterinary labelling as part of the drug review process, it remains the responsibility of the drug sponsor to ensure that the product monograph or the veterinary labelling is complete and accurate.

Current status:

Marketed

Current status date:

2001-02-20

Original market date: See footnote 1

2001-02-20

Product name:

ONE-ALPHA

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section .

DIN:

02242502

Product Monograph/Veterinary Labelling:

Date: 2017-08-14 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

LEO PHARMA INC
123 Commerce Valley Drive East, Suite 400
Thornhill
Ontario
Canada  L3T 7W8

Class: 

Human

Dosage form(s):

Liquid

Route(s) of administration:

Intravenous

Number of active ingredient(s):

1

Schedule(s):

Prescription  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

88:16.00   VITAMIN D

Anatomical Therapeutic Chemical (ATC): See footnote 4

A11CC03  ALFACALCIDOL

Active ingredient group (AIG) number:See footnote 5

0135700005

List of active ingredient(s)
Active ingredient(s) Strength
ALFACALCIDOL 2 MCG / ML

Application information

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